Actively Recruiting
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-08-07
50
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies aim to evaluate the initial efficacy of leflunomide tablets in second-line treatment of advanced MEN-1 neuroendocrine tumors, and to provide evidence for phase III clinical trials.
CONDITIONS
Official Title
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Pathological diagnosis of neuroendocrine tumor
- MEN-1 germ line mutation or tumor with somatic MEN-1 mutation
- Unresectable neuroendocrine tumors that failed standard first-line systemic therapy
- At least one lesion measurable by RECIST criteria
- ECOG performance status score of 0-1
- Voluntarily agree to participate, sign informed consent, and comply with follow-up
- Adequate bone marrow, liver, and kidney function as specified by laboratory values
You will not qualify if you...
- Received any antitumor therapy within 4 weeks prior
- Participating or participated in other drug trials within 4 weeks prior
- Major surgery or not recovered from surgery side effects within 4 weeks prior
- Other malignant tumors unless in complete remission for at least 2 years without treatment
- Persistent or active serious infections
- Uncontrolled hypertension with blood pressure over 150/90 mmHg
- Poorly controlled diabetes
- Grade II to IV congestive heart failure or heart block
- Recent history (within 6 months) of deep vein thrombosis, pulmonary embolism, myocardial infarction, serious arrhythmia, angina, coronary interventions, or acute coronary syndrome
- Allergy to leflunomide or its metabolites
- Severe liver damage
- Other severe acute or chronic medical conditions or lab abnormalities increasing risk or affecting study results
- Poor compliance or other conditions unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021
Actively Recruiting
Research Team
H
Hong Zhao
CONTACT
Y
Yihebali Chi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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